RECRUITING

Improving Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit)

Conditions

Bladder Cancer Breast Cancer Colon Cancer Endometrial Cancer Ovarian Cancer Rectal Cancer Prostate Cancer Renal Cell Carcinoma Kidney Cancer Cancer Survivors Nutrition

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This clinical trial studies the effect of four different intervention components "tools" on body weight, nutrition, and physical activity in cancer survivors. Studies indicate that people with a history of cancer whose nutrition and physical activity habits are consistent with the American Cancer Society's Nutrition and Physical Activity Guidelines may have longer disease-free survival. The four different intervention components may help patients with a history of cancer adopt recommended health behaviors after they have completed treatment.

Official Title

Optimizing Intervention Tools to Improve Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit)

Quick Facts

Study Start:2021-10-21

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05056077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. \>= 18 years of age. 2. Diagnosis of bladder, breast, colon, endometrial, kidney (renal cell carcinoma), ovarian, prostate, or rectal cancer. 3. Completed all cytotoxic chemotherapy, immunotherapy, targeted therapies, or radiation (if indicated) prior to enrollment. Hormonal treatments for breast and prostate cancer are allowed. 4. Owns a smart phone that has access to the Internet and can receive daily text messages. 5. Able to speak and read English or Spanish 6. Have a support person \>= 18 years of age who speaks English or Spanish and is willing to provide informed consent and support the participant throughout the study. 7. \>= 4 weeks since a major surgery to start of intervention (removal of port or catheter (cath) is not major surgery; reversal of ostomy is major surgery and will require at least 4 weeks prior to enrollment). 8. Readiness, as determined by the Physical Activity Readiness Questionnaire (PAR-Q). If there are any indications that home-based exercise might be unsafe based on PAR-Q, the patient will not be enrolled until confirmation from the patient's provider is received via email and/or phone that they are safe to exercise. Providers do not need to be contacted if patients answer 'yes' to 'Is your doctor currently prescribing any medication for your blood pressure or for a heart condition? 1. Identified by a cancer survivor participant who has consented to participate in Tools To Be Fit as their support person. 2. 18 years of age or older. 3. Speaks and reads English or Spanish. 4. Consents to complete two online surveys and four 1-on-1 health coaching calls during the 48 week study.	1. People with potential contraindications to home-based exercise based on the PAR-Q for whom the investigator is unable to obtain physician clearance. 2. ACS guideline score of \> 4 out of 6 at enrollment based on self-reported diet, BMI, and physical activity. Our screening survey will ask participants to report their height and weight; usual intake of foods in the ACS guidelines (e.g., red and processed meat, fruits, vegetables, grains); and the Godin Leisure Time Exercise Survey. 3. Used a physical activity tracker and a diet tracking app for \>= 1 week in the past 3 months; these are components of our digital health tool kit. 4. Planned major surgery during the study period (removal of port or cath or dermatological procedures excluded) 5. Scheduled to receive any form of cancer therapy during the study period with the exception of hormonal treatments for breast and prostate cancer, which are allowed. 6. History of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility. 7. History of psychiatric disorders that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent. 8. Participating in another weight loss, physical activity or dietary intervention clinical trial. Co-enrollment in some trials involving pharmacologic therapy is allowed. Participants are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial. 9. Currently pregnant or trying to become pregnant during the study period. 10. Living outside the United States during screening and/or the 48-week study period. 1. None.

Inclusion Criteria

Exclusion Criteria

1. \>= 18 years of age.
2. Diagnosis of bladder, breast, colon, endometrial, kidney (renal cell carcinoma), ovarian, prostate, or rectal cancer.
3. Completed all cytotoxic chemotherapy, immunotherapy, targeted therapies, or radiation (if indicated) prior to enrollment. Hormonal treatments for breast and prostate cancer are allowed.
4. Owns a smart phone that has access to the Internet and can receive daily text messages.
5. Able to speak and read English or Spanish
6. Have a support person \>= 18 years of age who speaks English or Spanish and is willing to provide informed consent and support the participant throughout the study.
7. \>= 4 weeks since a major surgery to start of intervention (removal of port or catheter (cath) is not major surgery; reversal of ostomy is major surgery and will require at least 4 weeks prior to enrollment).
8. Readiness, as determined by the Physical Activity Readiness Questionnaire (PAR-Q). If there are any indications that home-based exercise might be unsafe based on PAR-Q, the patient will not be enrolled until confirmation from the patient's provider is received via email and/or phone that they are safe to exercise. Providers do not need to be contacted if patients answer 'yes' to 'Is your doctor currently prescribing any medication for your blood pressure or for a heart condition?
1. Identified by a cancer survivor participant who has consented to participate in Tools To Be Fit as their support person.
2. 18 years of age or older.
3. Speaks and reads English or Spanish.
4. Consents to complete two online surveys and four 1-on-1 health coaching calls during the 48 week study.

1. People with potential contraindications to home-based exercise based on the PAR-Q for whom the investigator is unable to obtain physician clearance.
2. ACS guideline score of \> 4 out of 6 at enrollment based on self-reported diet, BMI, and physical activity. Our screening survey will ask participants to report their height and weight; usual intake of foods in the ACS guidelines (e.g., red and processed meat, fruits, vegetables, grains); and the Godin Leisure Time Exercise Survey.
3. Used a physical activity tracker and a diet tracking app for \>= 1 week in the past 3 months; these are components of our digital health tool kit.
4. Planned major surgery during the study period (removal of port or cath or dermatological procedures excluded)
5. Scheduled to receive any form of cancer therapy during the study period with the exception of hormonal treatments for breast and prostate cancer, which are allowed.
6. History of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
7. History of psychiatric disorders that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent.
8. Participating in another weight loss, physical activity or dietary intervention clinical trial. Co-enrollment in some trials involving pharmacologic therapy is allowed. Participants are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial.
9. Currently pregnant or trying to become pregnant during the study period.
10. Living outside the United States during screening and/or the 48-week study period.
1. None.

Contacts and Locations

Study Contact

Paige Steiding

CONTACT

(415) 514-6314

paige.steiding@ucsf.edu

Principal Investigator

Erin Van Blarigan, ScD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Erin Van Blarigan, ScD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-21

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2021-10-21

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Cancer Survivors
Nutrition

Additional Relevant MeSH Terms

Bladder Cancer
Breast Cancer
Colon Cancer
Endometrial Cancer
Ovarian Cancer
Rectal Cancer
Prostate Cancer
Renal Cell Carcinoma
Kidney Cancer